By Nancy C. Wilker, a member of our Life Sciences Practice Group
The biotechnology and pharmaceutical industries felt equal measures of relief and vindication from the Federal Circuit’s recent decision that isolated DNA molecules continue to be patentable subject matter. The case examined seven patents held by Myriad Genetics, Inc., which dominates the U.S. market for screening women for breast cancer.
In Assoc. for Molecular Pathology v. U.S. Patent and Trademark Office, widely known as the Myriad Genetics case, the Federal Circuit held that isolated DNA molecules are patentable subject matter because they are not products of nature. On the other hand, certain diagnostic screening methods using the DNA sequences are not patentable subject matter, since they failed the “machine or transformation” test.
The court reversed the most controversial portions of a federal judge’s 2010 ruling that, as we discussed at the time, deeply unsettled the biotech industry. That judge had held that isolated DNA corresponding to genomic DNA sequences are unpatentable products of nature, and that Myriad’s method claims were unpatentable because they disclosed no meaningful transformation.
Myriad’s patents at issue cover two genes, BRCA1 and BRCA2, that are frequently mutated in women with a propensity to develop breast cancer. A coalition of patients, physician groups, and the American Civil Liberties Union sued Myriad, asserting that the patents were invalid under Section 101 of the patent act as being drawn to unpatentable subject matter. Under that statute, a patent may be obtained for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”
Oddly enough, even though the U.S. Patent Office has granted patents covering isolated DNA claims for the past 30 years, the Department of Justice’s amicus brief supported the district court judge’s holding that genes were not patentable subject matter. [Read the full article]
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